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Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole

Primary Purpose

Macular Holes, Retinal Detachment

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Visio-AMTRIX
Sponsored by
TBF Genie Tissulaire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Holes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Man or woman over 18 years of age, less than 75 years
  • Macular Hole of all etiologies
  • Patient with history of opened macular hole after previous pars plana vitrectomy
  • Delay between previous surgery and inclusion (relapse or non-closing hole) > 1 month
  • Patient who received the study information and provided consent
  • Patient who is a members or a beneficiary of a national health insurance plan

Exclusion Criteria:

  • Ocular surgery other than the macular hole surgery in the prior 3 months
  • Participation in other clinical studies in the prior 3 months
  • Any current or prior ocular pathology that could interfere with the conduct of the study, including visually significant cataract or media opacity
  • Patient with uncontrolled glaucoma on more than 1 intraocular lowering medication
  • Patient with uveitis or other active ocular inflammation or infection
  • Pregnant or breast-feeding woman. Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study or to use an effective birth control method
  • Person deprived of liberty by judicial or administrative measures
  • Any other reason which in the opinion of the investigator would preclude the adherence of the schedules visits, safe participation in the study or affect the results of the study

Sites / Locations

  • Hôpital de la Croix-Rousse, Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Visio-AMTRIX

Arm Description

Disk of amniotic membrane apposed or buried on recurrent macular hole by the Investigator after vitrectomy and fluid-gas exchange.

Outcomes

Primary Outcome Measures

Closure of recurrent macular hole
Macular hole closure evaluated by optical coherence tomography (OCT)

Secondary Outcome Measures

Absence of adverse reaction
Analysis of all adverse events and comparison with adverse events observed after vitrectomy
Functional restoration after closure of the macular hole
Best corrected visual acuity (BCVA) and microperimetry assessment
Anatomical restoration
Anatomical restoration of the outer segments (external limiting membrane and ellipsoid layer). Anatomical changes in the ganglion cell layer of the retina in the area around the hole and under the membrane. The assessment is done by OCT measuring the thickness of the ganglion cell layer
Evaluation of the surgical technique of placing the membrane
Duration of coverage by Visio-AMTRIX and persistent after gas removal

Full Information

First Posted
December 29, 2021
Last Updated
April 28, 2023
Sponsor
TBF Genie Tissulaire
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1. Study Identification

Unique Protocol Identification Number
NCT05191628
Brief Title
Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole
Official Title
Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Low accrual rate
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
October 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TBF Genie Tissulaire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this open, multicenter trial is to assess the impact of the use of an amniotic membrane graft on the closure of macular hole-associated retinal detachment in patients with failed previous macular surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes, Retinal Detachment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Visio-AMTRIX
Arm Type
Experimental
Arm Description
Disk of amniotic membrane apposed or buried on recurrent macular hole by the Investigator after vitrectomy and fluid-gas exchange.
Intervention Type
Biological
Intervention Name(s)
Visio-AMTRIX
Intervention Description
Chemically-treated, viro-inactivated, freeze-dried and irradiated amniotic membrane placed by the investigator during macular hole surgery
Primary Outcome Measure Information:
Title
Closure of recurrent macular hole
Description
Macular hole closure evaluated by optical coherence tomography (OCT)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Absence of adverse reaction
Description
Analysis of all adverse events and comparison with adverse events observed after vitrectomy
Time Frame
7 days, 15 days, 1 month, 3 months, 6 months
Title
Functional restoration after closure of the macular hole
Description
Best corrected visual acuity (BCVA) and microperimetry assessment
Time Frame
7 days, 15 days, 1 month, 3 months, 6 months
Title
Anatomical restoration
Description
Anatomical restoration of the outer segments (external limiting membrane and ellipsoid layer). Anatomical changes in the ganglion cell layer of the retina in the area around the hole and under the membrane. The assessment is done by OCT measuring the thickness of the ganglion cell layer
Time Frame
1 month, 3 months, 6 months
Title
Evaluation of the surgical technique of placing the membrane
Description
Duration of coverage by Visio-AMTRIX and persistent after gas removal
Time Frame
7 days, 15 days, 1 month, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Man or woman over 18 years of age, less than 75 years Macular Hole of all etiologies Patient with history of opened macular hole after previous pars plana vitrectomy Delay between previous surgery and inclusion (relapse or non-closing hole) > 1 month Patient who received the study information and provided consent Patient who is a members or a beneficiary of a national health insurance plan Exclusion Criteria: Ocular surgery other than the macular hole surgery in the prior 3 months Participation in other clinical studies in the prior 3 months Any current or prior ocular pathology that could interfere with the conduct of the study, including visually significant cataract or media opacity Patient with uncontrolled glaucoma on more than 1 intraocular lowering medication Patient with uveitis or other active ocular inflammation or infection Pregnant or breast-feeding woman. Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study or to use an effective birth control method Person deprived of liberty by judicial or administrative measures Any other reason which in the opinion of the investigator would preclude the adherence of the schedules visits, safe participation in the study or affect the results of the study
Facility Information:
Facility Name
Hôpital de la Croix-Rousse, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69004
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole

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